Zoll Circulation, Inc. - December 14, 2010
Issue Date
Dec 14, 2010
Region
Pacific
Category
Device
$117.00
Address 1
650 Almanor Ave.
City
Sunnyvale
State
CA
Zip/Postal Code
94085-3513
Country
US
Inspection Range
Dec 06, 2010 - Dec 14, 2010
Pages
3
First Observation
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
Specifically, during a review of our Complaint and Service Log spreadsheet for the time frame of 7/30/2008 to 12/1/2010 and CCR/RMA reports, it was revealed that a number of customer calls classified as complaint and non-complaint situations where the AutoPulse System would stop operating pre-maturely due to battery/power issues, the emergency personnel had to revert to manual compressions. These events have not been reported to the Agency under the Medical Device Reporting requirements.
Investigator(s): Mark E. ChanSpecifically, during a review of our Complaint and Service Log spreadsheet for the time frame of 7/30/2008 to 12/1/2010 and CCR/RMA reports, it was revealed that a number of customer calls classified as complaint and non-complaint situations where the AutoPulse System would stop operating pre-maturely due to battery/power issues, the emergency personnel had to revert to manual compressions. These events have not been reported to the Agency under the Medical Device Reporting requirements.